Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
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Purpose
Magnesium is the second most abundant ion in human cells and plays fundamental roles in several enzymatic reactions: it is involved in ATP production, in the phosphorylation of proteins, in glucose metabolism and in the contraction of cytoskeleton.
Several epidemiological studies demonstrated that low dietary magnesium intake is inversely associated with diabetes mellitus, hypertension and metabolic syndrome.
Magnesium could be related to important haemodynamic and metabolic anomalies: at vascular level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium is involved in the physiopathological mechanism of insulin resistance, through a reduction in cellular uptake of glucose. This condition and the subsequent compensatory hyperinsulinemia can ultimately lead to increased synthesis of proinflammatory cytokines and to endothelial dysfunction. Thus, magnesium depletion and subsequent alterations can increase the risk of developing vascular disease such as atherosclerosis and has been associated with cardiovascular events.
Several clinical trials have explored the possible beneficial effect of magnesium supplementation on blood pressure, plasma lipids and insulin resistance but the results are often contradictory. One of the possibilities for these unclear results could be that in some of them the interventions started too late when haemodynamic and metabolic changes are more difficult to revert.
The investigators hypothesis is that magnesium supplementation in a population at increased genetic risk of developing metabolic syndrome but without it could improve blood pressure and the other metabolic syndrome related components.
Thus, the aim of the present study is to evaluate the effect of oral supplementation of magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a sample of 15 subjects who are at increased risk of developing metabolic syndrome since have a positive familiar history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).
| Condition | Intervention | Phase |
|---|---|---|
|
Family History of Metabolic Syndrome Family History of Diabetes |
Drug: magnesium pidolate Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome |
- Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Blood pressure measured in the lying and standing position (average of three measurements);
- other features of metabolic syndrome [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]especially plasma lipids and HOMA index
- endothelial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]endothelial function as measured non-invasively by ultrasound using the "Flow Mediated Dilatation" (FMD) technique
- arterial stiffness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]systemic and local arterial stiffness measured by digital photoplethysmography and by carotid ultrasound
- Inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Markers of inflammation such as C reactive protein
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: magnesium pidolate
administration of 8.1 mmol bid of magnesium pidolate for 8 weeks
|
Drug: magnesium pidolate
administration of 8.1 mmol bid of magnesium pidolate
|
|
Placebo Comparator: placebo
administration of 8.1 mmol bid of placebo for 8 weeks
|
Drug: placebo
administration of 8.1 mmol bid of placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- positive family history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI criteria).
Exclusion Criteria:
- any therapy related to metabolic syndrome (that is antihypertensive, anti diabetic, antilipemic drugs);
- age < 18 years or >50 years;
- previously diagnosed hypertension or immediate need for antihypertensive therapy (BP≥160/100);
- diabetes mellitus (ADA criteria);
- obesity (BMI>30Kg/m2);
- Continuative use of NSAIDs, magnesium or vitamin supplements;
- Hypermagnesaemia;
- Previous cardio- or cerebrovascular events;
- chronic kidney or liver or inflammatory or neoplastic disease;
- gastrointestinal dysfunction with hypomotility;
- active smoke (>5 cigarettes per day);
- Impossibility to give informed consent.
Contacts and Locations| Contact: Cristiano Fava, MD, PhD | 00390458124732 | cristiano.fava@univr.it |
| Contact: Pietro Delva, MD | 00390458124535 | pietro.delva@univr.it |
| Italy | |
| Azienda Ospedaliera Universitaria Integrata - Division of Internal Medicine C | Recruiting |
| Verona, VR, Italy, 37134 | |
| Principal Investigator: | Pietro Delva, MD | Universita of Verona |
| Principal Investigator: | Cristiano Fava, MD, PhD | Universita of Verona |
More Information
No publications provided
| Responsible Party: | dr. Pietro Delva, University of Verona |
| ClinicalTrials.gov Identifier: | NCT01181830 History of Changes |
| Other Study ID Numbers: | CF_Mg_fam_MetS |
| Study First Received: | August 12, 2010 |
| Last Updated: | August 12, 2010 |
| Health Authority: | Italy: Agenzia Italiana del Farmaco (AIFA) |
Keywords provided by Universita di Verona:
|
magnesium metabolic syndrome diabetes family history |
Additional relevant MeSH terms:
|
Diabetes Mellitus Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on June 18, 2013